New · posted Nov 10
STERIS · Medical Devices
Manager, Software Quality Assurance
- Remote, US
- Remote
- Full-time
- Manager
The role
As the Manager of Software Quality & Assurance is responsible for the overall quality of software products delivered. In this role you will define policies and procedures governing the testing of software systems including writing and maintaining test cases, executing and automating testing, and documenting test results. You will work closely with business process owners and users to ensure software systems are tested and validated where appropriate. In this role you will will also perform duties across many areas of the Software Development Lifecycle from requirements gathering to software testing with a focus on ensuring quality practices throughout. As a qualified candidate you must be familiar with a variety of technologies including enterprise software products, web applications, desktop applications, mobile applications, database systems, and business intelligence tools.
This is a remote role with the requirement of a start time no later than 8am CST.
Other
- Strong understanding of all phases of the application development lifecycle and project management disciplines.
- Ability to lead teams and provide regular coaching sessions, reviews and develop plans to improve skill sets.
- Strong professional verbal and written communication skills.
- Strong analytical skills and technical skills.
- Manages projects and a proven record of meeting project deadlines.
- Ability to identify root cause for complex problems and issues in applications / systems and implement permanent solutions.
- Ability to work with minimal supervision.
- Ability to adapt to frequently changing priorities.
- Ability to partner with contract resources in the best interest of STERIS.
What STERIS Offers
We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.
What you need
Required
- Bachelor's degree.
- Minimum of 10 years experience in software quality assurance field.
- Demonstrated ability to develop and implement effective testing strategies specifically in a regulated environment.
- Working knowledge of system and application architecture, and design.
- Experience with automation testing, performance engineering, CI/CD, release management and deployment processes
- Variety of programming languages and technologies.
- Experience leading or managing staff directly as well as sourced teams.
- Demonstrated ability to assess User needs, creatively approach solutions, and influence appropriate outcomes.
Preferrednice to have
- Advanced experience working and mentoring others in an Agile environment.
- Functional experience with DevOps.
- Functional experience with PaaS model, Azure cloud services.
- Knowledge in API design & development and microservices architecture.
- Certification in development tools, SDLC, Agile and/or project management preferred.
Skills named in this posting
What you'll do
What You'll do as a Manager, Software Quality Assurance
- Manage software quality and assurance team delivering solutions for our external and internal Customers.
- Recruit, hire, mentor and coach software quality and assurance professionals at different levels of experience and skills. Set expectations and provide timely and open feedback to foster continual individual development.
- Develop software quality standards within the software development lifecycle. Collaborate on the development of the test automation architecture and strategy. Ensure team’s activity is aligned to leverage test automation as appropriate.
- Ensure Business Systems managed solutions comply with regulatory controls including but not limited to SOX & ISO QS 13485.
- Collaborate with team members to translate requirements into test strategies, test plans and test cases. Work with team to execute test scripts documenting results and issues into tracking system.
- Partner with Systems Analyst and Business Users to facilitate User Acceptance testing and Business owner approval of solutions and solution changes. As required complete Software Validation documentation to support regulatory requirements.
- Lead Agile processes, coach cross-functional teams, collaborate with stakeholders, and foster an Agile culture for delivering quality products, while mentoring team members and optimizing value delivery.
- Plan and align multiple teams and resources per project requirements. Monitor activities and helps team remove roadblocks. Apply a broad knowledge of system testing and quality assurance standards and methodologies to ensure solutions satisfy end user requirements.
- Own all operational metrics. Share and collaborate with Business Systems leader to identify opportunities to improve delivered quality and identify detects earlier in the development cycle.
- Drive improvements in software testing practices. Stays abreast of new technology and recommends applications and tools to reduce development cycle time and increase product quality and security.
- Manage a team of 5 direct reports.
Pay and benefits
$112,000 – $132,000 a year
Employer providedPay range for this opportunity is $112,000.00 - $132,000.00, dependent on experience and skillset. This position is eligible for bonus participation.
Here is just a brief overview of what we offer
Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental, and Vision benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity & Parental Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term career
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits: STERIS Benefits
Open until position is filled.
Equal opportunity, accessibility and legal noticesSTERIS's statements, word for word
STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law. We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.
Job intelligence
The context around this role
Live data · November 10, 2026
Salary intelligence
How the pay compares
This role's midpoint is 22% below the US median for Software Quality & CSV roles at this level.
This roleEmployer provided
Manager roles in the US5 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $112,000 | — | $132,000 |
| All US (middle half) | $122,000 | $156,000 | $162,500 |
This role: STERIS's own published range. Comparisons: the base pay employers published on open Software Quality & CSV roles at the same level on Regulatory Jobs, November 10, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Software Quality & CSV
The general path across 57 open Software Quality & CSV roles on Regulatory Jobs, with the titles they carry most. Not STERIS's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 36 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership13
- Lab testing and methods9
- Data and digital systems7
- Documentation and SOPs5
- Validation and qualification2
- Investigations and CAPA1
- Quality systems and risk1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Software Quality & CSV work in medical devices, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devicesNamed in the posting
- FDAFDA Computer Software Assurance(official source, opens in a new tab)Risk-based assurance for production and quality system software
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices, aligned with ISO 13485
- ISOISO 14971(official source, opens in a new tab)Application of risk management to medical devices
- FDAFDA cybersecurity in medical devices(official source, opens in a new tab)Quality system considerations and premarket content for device cybersecurity
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- IMDRFIMDRF(official source, opens in a new tab)International Medical Device Regulators Forum guidance, including software as a medical device
- IECIEC 62366-1(official source, opens in a new tab)Application of usability engineering to medical devices
- EUEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation: CE marking, technical documentation, vigilance
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- IECIEC 60601-1(official source, opens in a new tab)Basic safety and essential performance of medical electrical equipment
- FDA21 CFR Part 830 (UDI)(official source, opens in a new tab)Unique device identification and the GUDID database
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
Company hiring pulse
STERIS on Regulatory Jobs
- 40
- Open roles
- 40
- Distinct roles
- 17
- Locations
By discipline
- Quality37 93%
- Regulatory3 8%
By level
- Associate & Specialist22 55%
- Senior & Principal10 25%
- Manager7 18%
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Manager, Software Quality Assurance at STERIS
Open until filled. $112K–$132K a year, employer provided.